HPV vaccine intake is down about 50% in Ireland. The vaccine industry announced a new push to promote Gardasil.

Paul Cullen, The Irish Times, Sep 16, 2017

What a difference a decade makes. In 2008 hundreds marched in Dublin to protest against the government's decision not to introduce a cervical cancer vaccine. Thousands signed a petition against the decision, taken because of the state of the nation's finances.

There were calls for minister for health Mary Harney to step down over the issue, and one government TD resigned the whip.

Then soap actress Jade Goody died of cervical cancer, the minister relented, and the Gardasil vaccine was provided to adolescent girls from 2010.

Today a very nervous health service is embarking on a seventh yearly round of immunising schoolchildren against the HPV virus that causes cervical cancer, knowing that future of the programme is at stake.

In the space of a few years, the uptake for the vaccine has plummeted from a high of 87 per cent to 50 per cent. Any further decline is likely to call into question the economic, medical and political rationale of the programme.

The battle for the hearts and minds of the 30,000 parents who will decide this month whether their daughters should receive the vaccine is long under way. For five years now opponents of the vaccine have been exploiting the potential of social media to deliver their emotion-laden message directly to parents. Central to their case is the claim that hundreds of girls have suffered chronic ill-health after taking the Gardasil vaccine.

Not a single verified case demonstrating a causal link between the girls' symptoms and the vaccine has been adduced during this time. Neither has any Irish medical authority come forward to say there is, or they think there is, a link between the symptoms and the vaccine.

Neither of these facts has dented the surge in "no smoke without fire" sentiment, driven online by a relentless diet of fake news and commentary from the anti-vax movement in the US and other dubious sources.

It is human nature to attribute cause even when evidence is lacking, and to look for reinforcement of your views. This happens easily online

Human nature

"It is human nature to attribute cause even when evidence is lacking, and to look for reinforcement of your views. This happens easily online," says Dr Eoin O'Dell, a law lecturer with an interest in internet regulation.

He says under Facebook's algorithms the more you get involved in something the more it serves you up that something, be it a local GAA team or anti-vax propaganda. "People also get disinhibited very quickly online; when it's just you, the keyboard and the screen things go to extremes quickly."

What has changed this autumn is that the Health Service Executive (HSE) has - finally - awoken from its slumber. Late last month it used the occasion of the annual launch of the immunisation programme to tell the anti-vaccine lobby "the gloves are off".

With Minister for Health Simon Harris telling groups to "butt out" of debate and HSE boss Tony O'Brien accusing them of "emotional terrorism", the stage is set for a vitriolic struggle between the two sides.

The pitch was very much left to the vaccine deniers up to recently

"Not very wise," says one PR professional of the Minister's "butt out" remark, "given the many well-intentioned parents genuinely concerned at the persistent reports of adverse impacts from the medicine".

"That said," he adds, "it took a very long time for the department and the HSE to fight back by challenging the allegations of major side-effects and pointing out that the relative numbers are tiny. The pitch was very much left to the vaccine deniers up to recently."

Wars of words

While the remarks by Harris and O'Brien provoked the inevitable wars of words, the most serious message delivered at the launch came from three prominent women scientists pleading the case for families to ensure adolescent girls get the HPV vaccine.

The trio - a paediatrician, an obstetrician and a psychologist - delivered their contributions with passion and scientific rigour, while candidly admitting to their own moments of doubt, since overcome. And just in case anyone claimed otherwise, they either had had their own children vaccinated or would be doing so when they got older.

One of the women, paediatrician Prof Karina Butler, pointed out she has been treating young girls with the symptoms described by anti-vaccine activists for decades, long before Gardasil was introduced.

The Health Products Regulatory Authority (HPRA) has received 1,099 reports of adverse reactions and events associated with the use of the vaccine, of which 59 per cent were categorised as serious.

As The Irish Times reported this week, this equates to about 650 girls in Ireland reporting that they required medical intervention or treatment after receiving the vaccine.

Given that 230,000 girls have received the full course, this appears to indicate one in every 355 girls have required attention.

The HPRA says more than 80 per cent of the serious cases involved short-term "vaccination-related events" such as fainting and rashes.

That would leave 130 of the reports it has received relating to longer-term issues. Regret, the main group campaigning against the vaccines, quotes a figure of 450 girls having suffered serious adverse reactions.

Intervention

Any medical intervention carries a risk, as does any human activity. Yet most of us continue to fly, for example, because the risk involved is so low. The HPRA declined to provide comparative figures for adverse reaction reports for other medicines. To do so would be inaccurate and misleading, it said, because of factors such as the extent of their use and media coverage.

One point everyone agrees on is that there is a cohort of young people who have long-term health issues that are difficult to diagnose and treat.

Regret says they are Gardasil-related; in the medical literature they have been assigned various descriptions - chronic fatigue, ME, chronic disabling fatigue.

Their symptoms are real and protracted, and their illness causes massive upheaval

"The families I deal with are distressed, genuine people whose children are very sick," says paediatrician Prof Alf Nicholson. "Their symptoms are real and protracted, and their illness causes massive upheaval."

Many of the young people Prof Nicholson sees in Temple Street children's hospital are suffering from symptoms such as poor sleep, muscle and joint pain and malaise.

"These symptoms are the commonest cause of prolonged absence from secondary school in Ireland, yet we don't truly understand them. It's a complex condition requiring a complex response."

Prof Nicholson says there is "no evidence" Gardasil contributed to patients' condition. "I have plenty of boys under my care who are also suffering these post-viral fatigue symptoms."

Since the vaccine is not currently provided to boys - though there are plans to extend the immunisation programme - it cannot be blamed for these cases.

Safety studies

The World Health Organisation, is its latest bulletin on HPV vaccines from last June, says it considers HPV vaccines to be "extremely safe".

"There are now accumulated safety studies that include several million persons and which compare the risks for a wide range of health outcomes in vaccinated and unvaccinated subjects.

However, despite the extensive safety data available for this vaccine, attention has continued to focus on spurious case reports and unsubstantiated allegations."

The WHO expresses concern that "unsubstantiated allegations have a demonstrable negative impact on vaccine coverage in a growing number of countries, and that this will result in real harm".

Ireland, which accounts for one in five adverse reaction reports for the vaccine in the EU, must surely have been in the mind of the writer.

Prof Rose Anne Kenny sees about 100 girls a year with Postural orthostatic tachycardia syndrom (Pots), another condition that has been blamed on the vaccine, at the falls and blackout clinic at St James's Hospital. Between five and 10 families ask to discuss a possible association with Gardasil and the condition, which is characterised by abnormally large increases in heart rate when changing from lying down to an upright position.

"There is no objective evidence of a link or causal association between their symptoms and the vaccine," she says. "This has been studied in thousands of cases, and it has not been reported as an issue."

Fluid intake

The good news is that most young people with Pots recover well after a varied treatment regimen that includes muscle strengthening, sitting before standing and increased salt and fluid intake. Prof Kenny says most patients grow out of the problem as their cardiovascular system catches up with the rest of their growth.

Prof Nicholson points to previous vaccine scares - Pertussis (whooping cough) in the 1970s and the MMR jab in the 1990s - which were "completely discredited".

"It seems likely the same thing will happen to this one," he says.

Patients do tend to recover - slowly over a number of years - from chronic fatigue, but they require access to physiotherapy, psychologists, paediatricians and pain management specialists. "We have to do better in creating a proper care pathway for patients and their families to follow, but this can't be limited to people claiming a link to Gardasil. It has to be for boys too."

Jack & Jill Foundation founder Jonathan Irwin is one of those parents who believes the Gardasil vaccine is responsible for his daughter's ill-health. He says she fell ill within six months of receiving the vaccine four years ago and has yet to recover.

"She was a highly athletic achiever, riding her pony on the Irish team. Then, within months, she was in too much pain to even get on a horse. She was wiped out."

His daughter's symptoms included headaches, nausea and lethargy; she spent long periods bedridden and has missed her Junior Cert.

You know your own child. The tipping factor was the vaccine, that's why she fell ill. Parents know these things

Tipping factor

Asked how he could be certain the vaccine was responsible for his daughter's illness, he says: "You know your own child. The tipping factor was the vaccine, that's why she fell ill. Parents know these things."

He says her GP "wasn't interested", and further medical investigation in Ireland resulted in a "complete blank". He took his daughter to clinics in Germany and the US for treatment.

He says he decided to bring her to Germany after getting in contact with a family in England whose daughter had exactly the same symptoms. "They said all her bloods were shot to pieces and her immune system was down."

Though he says he isn't anti-vaccine Irwin goes on to express doubts about vaccines generally, and is also critical of the fluoridation of water. He questions the need to vaccinate against cervical cancer when it has been in decline "for years" due to better hygiene.

According to the National Cancer Registry, the number of cases of cervical cancer increased from 194 in 1994 to 327 in 2010, before dropping to 271 in 2014.

Symptoms

Attempts to contract a representative of Regret for this article were unsuccessful. Don Myers, spokesman for another group, Inform Parents, says he became involved in campaigning on the issue after his daughter was "damaged" by the vaccine in 2015.

He says her symptoms - including headaches, stomach and joint pains and a lack of concentration - emerged a week after she received Gardasil in school. Unhappy with the treatment provided by the health service, he says he has "gone down an alternative" route by sending his daughter to a kinesiologist.

If you buy a saucepan in a shop the manufacturer will have put their leaflet in it. Why should it be any different with the vaccine?

He says he is not anti-vaccine though he does believe Gardasil caused his daughter's illness. "We have never called for the vaccine to be withdrawn. Our campaign is solely based on patients being made aware of all the information."

Inform Parents says parents should be provided with a patient information leaflet for Gardasil before their children are vaccinated. "If you buy a saucepan in a shop the manufacturer will have put their leaflet in it. Why should it be any different with the vaccine?"

The main difference between this leaflet and the materials distributed by the HSE is that it lists the reported - as opposed to known - side-effects. The HSE says its materials include all the "known scientifically proven side-effects", and are written in clear simple language that can be easily understood.

The leaflet is available on its website and elsewhere online.

Swine flu

The HSE's difficulties with the HPV vaccine may be rooted in the mess that was made of the swine flu vaccination programme in 2010, the same year Gardasil was introduced.

Responding to the threat of a swine flu epidemic that appeared to be sweeping through Europe, the State rushed in supplies of two vaccines at great expense. Huge amounts of stock went unused as the threat receded. More seriously, there were reports of narcolepsy among people who received one of the vaccines.

"There was a direct surge in narcolepsy cases after the swine flu vaccine was given. We haven't seen a massive surge in chronic fatigue presentation post-Gardasil," says Prof Nicholson.

Another element in the nascent opposition to Gardasil resulted from the fact that it protects against diseases that are sexually transmitted. Traditional Catholic groups were among the first to oppose the introduction of the vaccine. Mothers Alliance Ireland argued that the "real cause" of cervical cancer was promiscuous sexual activity, not the HPV virus.

"We have to live in the real world," Prof Nicholson says in response to such arguments. "We know young people are more likely to be sexually active than in the past."

Stressful time

Some parents have argued the vaccine should be given later as the first year of secondary school is for many girls a stressful time.

Prof Nicholson says it makes sense for the vaccination programme to administer Gardasil before the possibility of sexual activity but there is "some logic" on an individual basis to leaving it later. "For parents it's an individual decision. I can see some merit in delaying the vaccine depending on family circumstances."

Ironically, the number of adverse reactions reported for Gardasil is dropping just as the debate is heating up. Reports fell from over 250 a year in 2010 and 2011 to 119 in 2016 and just 13 in the first four months of this year. Only some of this fall can be explained by declining uptake.